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Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Non-COVID-19 Acute Respiratory Distress Syndrome

Primary Purpose

Acute Respiratory Distress Syndrome, Ards

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
COVI-MSC
Placebo
Sponsored by
Sorrento Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome focused on measuring ARDS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Negative for SARS-CoV-2 infection as determined by an approved polymerase chain reaction (PCR) or an approved antigen test of any specimen
  • Hospitalized with non-COVID-19-induced ARDS (any severity) with a PaO2/FiO2 (PF ratio) ≤ 300
  • Requires oxygen supplementation at Screening
  • Willing to follow contraception guidelines

Exclusion Criteria:

  • Current standard of care treatments for ARDS appear to be working and the subject is clinically improving
  • A previous stem cell infusion unrelated to this trial
  • Pregnant or breast feeding or planning for either during the study
  • Suspected uncontrolled active bacterial, fungal, viral, or other infection
  • History of a splenectomy, lung transplant or lung lobectomy
  • Concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable)
  • Expected survival or time to withdrawal of life-sustaining treatments expected to be < 7 days

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    COVI-MSC

    Placebo

    Arm Description

    Subjects will receive intravenous infusions of COVI-MSC (two vials or a total of ≈ 30 million cells) on Day 0, Day 2, and Day 4

    Subjects will receive intravenous infusions of placebo (two vials) on Day 0, Day 2, and Day 4

    Outcomes

    Primary Outcome Measures

    All-cause mortality rate at Day 28
    All-cause mortality rate at Day 28

    Secondary Outcome Measures

    All-cause mortality rate at Days 60 and 90
    All-cause mortality rate at Days 60 and 90
    Number of ventilator-free days through Day 28
    Number of ventilator-free days through Day 28
    Number of ICU days through Day 28
    Number of ICU days through Day 28
    Clinical status at Day 28
    Clinical status as assessed using the Ordinal Scale for Clinical Improvement (0-8 scale, where lower score means better outcome)
    Change in oxygenation
    Change in oxygenation at Days 2, 4, 6, 14, and 28 as measured using PaO2:FiO2 ratio.

    Full Information

    First Posted
    May 29, 2021
    Last Updated
    September 17, 2021
    Sponsor
    Sorrento Therapeutics, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04909879
    Brief Title
    Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Non-COVID-19 Acute Respiratory Distress Syndrome
    Official Title
    Treatment of Non-COVID-19 Acute Respiratory Distress Syndrome: A Phase 2 Study of the Efficacy and Safety of Intravenous Allogeneic Adipose-Derived Mesenchymal Stem Cells
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Replaced by a different protocol.
    Study Start Date
    September 2021 (Anticipated)
    Primary Completion Date
    February 2022 (Anticipated)
    Study Completion Date
    April 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sorrento Therapeutics, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This is a Phase 2 randomized study to assess the safety and efficacy of COVI-MSC in the setting of current standard of care treatments for subjects hospitalized subjects with acute respiratory distress syndrome not related to COVID-19 infection.
    Detailed Description
    This is a Phase 2, randomized controlled, multicenter study to assess the safety and efficacy of COVI-MSC in the setting of current standard of care treatments for subjects hospitalized subjects with acute respiratory distress syndrome not related to COVID-19 infection. Subjects will be randomized 2:1 to receive COVI-MSC or placebo. COVI-MSC or placebo will be administered intravenously on Day 0, Day 2, and Day 4.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Respiratory Distress Syndrome, Ards
    Keywords
    ARDS

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    COVI-MSC
    Arm Type
    Experimental
    Arm Description
    Subjects will receive intravenous infusions of COVI-MSC (two vials or a total of ≈ 30 million cells) on Day 0, Day 2, and Day 4
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Subjects will receive intravenous infusions of placebo (two vials) on Day 0, Day 2, and Day 4
    Intervention Type
    Biological
    Intervention Name(s)
    COVI-MSC
    Intervention Description
    COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Excipient solution
    Primary Outcome Measure Information:
    Title
    All-cause mortality rate at Day 28
    Description
    All-cause mortality rate at Day 28
    Time Frame
    Baseline to Day 28
    Secondary Outcome Measure Information:
    Title
    All-cause mortality rate at Days 60 and 90
    Description
    All-cause mortality rate at Days 60 and 90
    Time Frame
    Baseline to Day 60 and Day 90
    Title
    Number of ventilator-free days through Day 28
    Description
    Number of ventilator-free days through Day 28
    Time Frame
    Baseline through Day 28
    Title
    Number of ICU days through Day 28
    Description
    Number of ICU days through Day 28
    Time Frame
    Baseline through Day 28
    Title
    Clinical status at Day 28
    Description
    Clinical status as assessed using the Ordinal Scale for Clinical Improvement (0-8 scale, where lower score means better outcome)
    Time Frame
    Baseline to Day 28
    Title
    Change in oxygenation
    Description
    Change in oxygenation at Days 2, 4, 6, 14, and 28 as measured using PaO2:FiO2 ratio.
    Time Frame
    Baseline to Day 2, Day 4, Day 6, Day 14, Day 28

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Negative for SARS-CoV-2 infection as determined by an approved polymerase chain reaction (PCR) or an approved antigen test of any specimen Hospitalized with non-COVID-19-induced ARDS (any severity) with a PaO2/FiO2 (PF ratio) ≤ 300 Requires oxygen supplementation at Screening Willing to follow contraception guidelines Exclusion Criteria: Current standard of care treatments for ARDS appear to be working and the subject is clinically improving A previous stem cell infusion unrelated to this trial Pregnant or breast feeding or planning for either during the study Suspected uncontrolled active bacterial, fungal, viral, or other infection History of a splenectomy, lung transplant or lung lobectomy Concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable) Expected survival or time to withdrawal of life-sustaining treatments expected to be < 7 days
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mike Royal, MD
    Organizational Affiliation
    Sorrento Therapeutics, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Non-COVID-19 Acute Respiratory Distress Syndrome

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